Fecal Microbial Transplantation in Treatment of Irritable Bowel Syndrome; a Double Blinded Placebo Controlled Trial.

NCT ID: NCT02154867

Last Updated: 2017-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-12-31

Brief Summary

Fecal Microbial Transplantation in Treatment of Irritable Bowel Syndrome; a Double Blinded Placebo Controlled Trial - the REFIT project

Irritable bowel syndrome (IBS) is a condition characterized by variable complaints like diarrhoea, bloating and abdominal pain, and may result in considerably reduced quality of life and increased sickness absence. The prevalence of IBS in the general population may be as high as 15 per cent depending on the diagnostic criteria used. The pathophysiology of IBS is poorly understood and theories of visceral hypersensitivity, micro-inflammation and other less well founded theories have been stated. So far, no measurement or test can affirm diagnosis, but exclusion of organic diseases in combination with a typical symptom pattern according to the Rome classification can set the diagnosis.

Earlier non-controlled case reports have shown a convincing effect of fecal microbial transplantation (FMT) in IBS patients. However, no placebo controlled trial has been performed in this condition. Changes in the gut microbiome may be an important factor in IBS pathogenesis. Microbiome analysis has revealed changes in microbiome composition that may trigger changes in visceral sensibility and pain perception.

The fecal microbial transplantation (FMT) procedure has been used primarily to treat clostridium difficile infections. Few minor side effects have been reported.

Hypothesis: IBS is caused by an imbalance of the gut microbiome that may be reset by transplanting a microbiome sample from a healthy donor.

Aim of study:

• To test the clinical effect of FMT in patients with IBS
• To describe the fecal microbiome in IBS patients
• To describe changes in the fecal microbiome of IBS patients following FMT

The REFIT study will perform a randomized placebo-controlled double blinded trial of FMT on IBS according to the Rome 3 criteria. A study group of 60 IBS (diarrhoea variant) patients will recruited from general practice and allocated to active (30) or placebo (30) by block randomization. Donors will be 15 healthy volunteers with no risk behaviour and a pre-screening for communicable diseases will be performed.

Outcome measures will be clinical assessment by IBS-severity scoring system (IBS-SSS) at 0, 1, 3, 6, and 12 months. Microbiome analysis will be performed by metagenomic sequencing (University of Tromsø) at 0, 3, and 12 months for patients, and at inclusion for donors.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Fecal transplantation

Fecal transplantation of freshly prepared feces from healthy donor. Application by colonoscope in proximal half of colon.

Group Type: EXPERIMENTAL

Fecal transplantation

Intervention Type: BIOLOGICAL

Preparation of flesh feces by blending in 0.9 % saline and crude filtering. The solution is applied in proximal colon of IBS patient by colonoscopy after standard bowel preparation.

Placebo fecal transplantation

Sham transplant subject's own feces. Application by colonoscope in proximal part of colon.

Group Type: PLACEBO_COMPARATOR

Placebo fecal transplant

Intervention Type: OTHER

Fecal transplantation with own feces

Interventions

Fecal transplantation

Preparation of flesh feces by blending in 0.9 % saline and crude filtering. The solution is applied in proximal colon of IBS patient by colonoscopy after standard bowel preparation.

Intervention Type: BIOLOGICAL

Placebo fecal transplant

Fecal transplantation with own feces

Intervention Type: OTHER

Other Intervention Names

Fecal microbial transplantation

Eligibility Criteria

Inclusion Criteria

• Patients with IBS-D according to Roma 3 criteria

• healthy volunteers

Exclusion Criteria

• Immunomodulating medication
• Nocturnal abdominal pain
• Constant abdominal pain
• Alarm symptoms like rectal bleeding, weight loss, nightsweats
• Symptomatic heart/vascular/lung disease
• Renal failure
• Known food allergy
• Microscopic/collagenous colitis
• non-compliant
• BMI <18

• Tattoos, imprisoning or piercing last 3 months
• Any history of chronic diarrhoea, constipation, inflammatory bowel disease, irritable bowel disease, colorectal polyps or cancer, immunosuppression, morbid obesity, metabolic syndrome, atopica, or fatigue
• positive test for hepatitis B, C, HIV, treponema pallidum
• sexual high risk habits
• antibiotic treatment in the past 3 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital of North Norway

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rasmus Goll, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of North Norway

Per C Valle, PhD

Role: STUDY_DIRECTOR

University Hospital of North Norway

Locations

University Hospital of North Norway

Harstad, , Norway

Countries

Norway

References

Goll R, Johnsen PH, Hjerde E, Diab J, Valle PC, Hilpusch F, Cavanagh JP. Effects of fecal microbiota transplantation in subjects with irritable bowel syndrome are mirrored by changes in gut microbiome. Gut Microbes. 2020 Nov 9;12(1):1794263. doi: 10.1080/19490976.2020.1794263.

Reference Type: DERIVED

PMID: 32991818 (View on PubMed)

Johnsen PH, Hilpusch F, Cavanagh JP, Leikanger IS, Kolstad C, Valle PC, Goll R. Faecal microbiota transplantation versus placebo for moderate-to-severe irritable bowel syndrome: a double-blind, randomised, placebo-controlled, parallel-group, single-centre trial. Lancet Gastroenterol Hepatol. 2018 Jan;3(1):17-24. doi: 10.1016/S2468-1253(17)30338-2. Epub 2017 Nov 1.

Reference Type: DERIVED

PMID: 29100842 (View on PubMed)

Other Identifiers

2013/971/REK

Identifier Type: -

Identifier Source: org_study_id